Job Description
Design Assurance Engineer III or Sr. Design Assurance Engineer | Direct Hire | $100-$127k + 10% Bonus | Fridley, MN
A well known medical device company is seeking a Design Assurance Engineer III or Sr. Design Assurance Engineer to help support large projects for medical devices that are complex parts and tight specifications and be a part of the Design Quality Team that's growing at a new R&D facility. This Engineer will have flexiblity, but mainly needs to be onsite.
* Represent Quality Assurance on product development teams, including developing Quality Plans and Risk Management Plans
* Support design and development project deliverables related to Design Controls, Risk Management, Design Verification and Validation to ensure meet applicable standards and regulatory requirements while ensuring a primary focus on patient safety and reliable product performance
* Design and/or specify inspection and testing procedures/systems to ensure products conform to specifications and quality standards
* Investigate/analyze customer complaints and support Regulatory Affairs to monitor customer complaint trends and maintain compliance to complaint system
* Support all functional departments to ensure compliance with Quality System and lead continuous improvement efforts of the Quality System.
Qualifications:
BS or MS: Mechanical or Biomedical Engineering (Engineering realm required)
5+ years as a Design Assurance Engineer
Medical Device industry experience (ISO 13485) required!